Efficacy and safety of concurrent chemoradiation with weekly cisplatin ± low-dose celecoxib in locally advanced undifferentiated nasopharyngeal carcinoma: A phase II-III clinical trial

• Published in: Journal of cancer research and therapeutics 2012-02, Vol.7 (4)
• Main Authors: Mohammadianpanah, Mohammad, Razmjou-Ghalaei, Sasan, Shafizad, Amin, Ashouri-Taziani, Yaghoub, Khademi, Bijan, Ahmadloo, Niloofar, Ansari, Mansour, Omidvari, Shapour, Mosalaei, Ahmad, Mosleh-Shirazi, Mohammad Amin
• Format: Article
• Language: English
• Subjects: Celecoxib, chemotherapy, concurrent chemoradiation, cyclooxygenase-2 (COX-2) inhibitors, locally advanced undifferentiated nasopharyngeal carcinoma, weekly cisplatin
• ISSN: 0973-1482

Background: This is the first study that aimed to determine the efficacy and safety of concurrent chemoradiation with weekly cisplatin ± celecoxib 100 mg twice daily in locally advanced undifferentiated nasopharyngeal carcinoma. Materials and Methods: Eligible patients had newly diagnosed locally advanced (T3-T4, and/or N2-N3, M0) undifferentiated nasopharyngeal carcinoma, no prior therapy, Karnofsky performance status ≥ 70, and normal organ function. The patients were assigned to receive 7 weeks concurrent chemoradiation (70 Gy) with weekly cisplatin 30 mg/m 2 with either celecoxib 100 mg twice daily, (study group, n = 26) or placebo (control group, n = 27) followed by adjuvant combined chemotherapy with cisplatin 70 mg/m 2 on day 1 plus 5-fluorouracil 750 mg/m 2 /d with 8-h infusion on days 1-3, 3-weekly for 3 cycles. Results: Overall clinical response rate was 100% in both groups. Complete and partial clinical response rates were 64% and 36% in the study group and 44% and 56% in the control group, respectively (P > 0.25). The addition of celecoxib to concurrent chemoradiation was associated with improved 2-year locoregional control rate from 84% to 100% (P = 0.039). Conclusions: The addition of celecoxib 100 mg twice daily to concurrent chemoradiation improved 2-year locoregional control rate.